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HRP20161414T1 - Nove formulacije cjepiva s pomoćnim sredstvima koja sadrže saponin - Google Patents

Nove formulacije cjepiva s pomoćnim sredstvima koja sadrže saponin Download PDF

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Publication number
HRP20161414T1
HRP20161414T1 HRP20161414TT HRP20161414T HRP20161414T1 HR P20161414 T1 HRP20161414 T1 HR P20161414T1 HR P20161414T T HRP20161414T T HR P20161414TT HR P20161414 T HRP20161414 T HR P20161414T HR P20161414 T1 HRP20161414 T1 HR P20161414T1
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Croatia
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volume
ethoxylated
fatty acid
sorbitan
concentration
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HRP20161414TT
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English (en)
Inventor
Noel Joseph Francois Detraz
Guillaume Rigaut
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Merial, Inc.
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Publication of HRP20161414T1 publication Critical patent/HRP20161414T1/hr

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    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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Claims (14)

1. Sastav cjepiva koji sadrži emulziju s uljem u vodi (O/W) za injekciju, naznačen time, da obuhvaća sljedeće: (i) vodena otopina koja sadrži najmanje jedan imunogen koji je neaktivirani virus bolesti FMD („Foot-and-Mouth disease“ – bolest stopala i usta), neaktivirani svinjski cirkovirus tipa 2 (PCV-2-virus), ili neaktivirana bakterija Mycoplasma hyopneumoniae; (ii) vodena otopina koja sadrži saponin u količini od 0,35 mg/doza do 3,0 mg/doza; (iii) vodena otopina koja sadrži aluminijev hidroksid, gdje je koncentracija aluminijevog hidroksida od 0,065% do 1,0% masa/volumen; (iv) mineralno ulje; (v) neionski lipofilni tenzid; (vi) neionski hidrofilni tenzid koji ima visoku vrijednost hidrofilno-lipofilne ravnoteže (visoku HLB-vrijednost) – između 13 i 40; i (vii) neionski hidrofilni tenzid koji ima nisku vrijednost hidrofilno-lipofilne ravnoteže (nisku HLB-vrijednost) – između 9 i 13.
2. Sastav cjepiva prema zahtjevu 1, naznačen time, da je neionski hidrofilni tenzid visoke HLB-vrijednosti prisutan s koncentracijom od 0,1% do 1,5% izraženom kao masa po volumenu emulzije (masa/volumen), i pri čemu je ukupna koncentracija tenzida od 4% do oko 8% prema masi po volumenu emulzije (masa/volumen).
3. Sastav cjepiva prema zahtjevu 1, naznačen time, da je neionski hidrofilni tenzid niske HLB-vrijednosti prisutan s koncentracijom od 1% do 8% izraženom kao masa po volumenu emulzije (masa/volumen).
4. Sastav cjepiva prema zahtjevu 1, naznačen time, da je neionski lipofilni tenzid prisutan s koncentracijom od 0,1% do 2,5% izraženom kao masa po volumenu emulzije (masa/volumen).
5. Sastav cjepiva prema zahtjevu 1, naznačen time, da je mineralno ulje prisutno s koncentracijom od 20% do 40% (volumen/volumen), i pri čemu emulzija ima temperaturu inverzne faze (PIT) od oko 33°C do oko 66°C.
6. Sastav cjepiva prema zahtjevu 1, naznačen time, da je neionski hidrofilni tenzid niske HLB-vrijednosti odabran iz skupine koju čine etoksilirani triesteri masne kiseline od sorbitana, etoksilirani diesteri masne kiseline od sorbitana, etoksilirani monoesteri masne kiseline od sorbitana, etoksilirani masni alkoholi, etoksilirane masne kiseline, etoksilirano ricinusovo ulje i njihove kombinacije, te time, da je ester od navedenih etoksiliranih estera masne kiseline, odabran iz skupine koju čine oleat, palmitat, stearat, izostearat, laurat i njihove kombinacije.
7. Sastav cjepiva prema zahtjevu 1, naznačen time, da je neionski lipofilni tenzid odabran iz skupine koju čine esteri masne kiseline od sorbitana, esteri masne kiseline od manida, dietoksilirani esteri masne kiseline od manida, trietoksilirani esteri masne kiseline od manida, tetraetoksilirani esteri masne kiseline od manida i njihove kombinacije, te time, da je ester od navedenih estera masne kiseline, odabran iz skupine koju čine oleat, palmitat, stearat, izostearat, laurat i njihove kombinacije.
8. Sastav cjepiva prema zahtjevu 1, naznačen time, da je mineralno ulje odabrano iz skupine koju čine parafinsko ulje, skualan, pristan, poliizobutensko ulje, hidrogenizirano poliizobutensko ulje, polidekensko ulje, poliizoprensko ulje, poliizopropensko ulje i njihove kombinacije.
9. Sastav cjepiva prema zahtjevu 1, naznačen time, da obuhvaća parafinsko ulje, monoester sorbitanske masne kiseline kao neionski lipofilni tenzid, etoksilirani triester masne kiseline od sorbitana kao neionski hidrofilni tenzid niske HLB-vrijednosti i neionski blok-kopolimer kao neionski hidrofilni tenzid visoke HLB-vrijednosti.
10. Sastav cjepiva prema zahtjevu 1, naznačen time, da je neionski hidrofilni tenzid visoke HLB-vrijednosti odabran iz skupine koju čine etoksilirani monoesteri masne kiseline od sorbitana, etoksilirani masni alkoholi, etoksilirane masne kiseline, neionski blok-kopolimer i njihove kombinacije, te time, da je etoksilirani monoester od sorbitana, odabran iz skupine koju čine etoksilirani sorbitan-monolaurat, etoksilirani sorbitan-monopalmitat, etoksilirani sorbitan-monostearat, etoksilirani sorbitan-monooleat i njihove kombinacije.
11. Sastav cjepiva prema zahtjevu 9, naznačen time, da monoester sorbitanske masne kiseline je sorbitan-monooleat, etoksilirani triester masne kiseline od sorbitana je etoksilirani trioleat od sorbitana i neionski blok-kopolimer je polioksietilen/polioksipropilen-polimer (POE-POP).
12. Sastav cjepiva prema zahtjevu 11, naznačen time, da je parafinsko ulje prisutno u koncentraciji od 10% do 40% volumen/volumen, sorbitan-monooleat je prisutan u koncentraciji od 0,2% do 1,5% masa/volumen, etoksilirani trioleat od sorbitana je prisutan u koncentraciji od 2% do 5% masa/volumen i POE-POP je prisutan u koncentraciji od 0,1% do 0,5% masa/volumen; ili je parafinsko ulje prisutno u koncentraciji od 29,3% volumen/volumen, sorbitan-monooleat je prisutan u koncentraciji od 0,6% masa/volumen, etoksilirani trioleat od sorbitana je prisutan u koncentraciji od 3,4% masa/volumen i POE-POP je prisutan u koncentraciji od 0,25% masa/volumen.
13. Sastav cjepiva prema zahtjevu 11, naznačen time, da se upotrebljava za induciranje imunološke reakcije protiv patogena kod životinja.
14. Sastav cjepiva za uporabu prema zahtjevu 13, naznačen time, da se sastav cjepiva primjenjuje pomoću intramuskularne (IM), intradermalne (ID) ili subkutane (SC) injekcije, ili se davanje cjepiva izvodi putem injektora bez igle.
HRP20161414TT 2009-09-10 2016-10-27 Nove formulacije cjepiva s pomoćnim sredstvima koja sadrže saponin HRP20161414T1 (hr)

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Application Number Priority Date Filing Date Title
US24117109P 2009-09-10 2009-09-10
PCT/US2010/048256 WO2011031850A1 (en) 2009-09-10 2010-09-09 New vaccine formulations comprising saponin-containing adjuvants
EP10757885.8A EP2475384B1 (en) 2009-09-10 2010-09-09 New vaccine formulations comprising saponin-containing adjuvants

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HRP20161414T1 true HRP20161414T1 (hr) 2016-12-02

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US (2) US9107859B2 (hr)
EP (1) EP2475384B1 (hr)
JP (1) JP5759463B2 (hr)
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